Status:
COMPLETED
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in At-Risk Adults
Lead Sponsor:
PLx Pharma
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Gastroduodenal Ulcerations
Erosion
Eligibility:
All Genders
50-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.
Eligibility Criteria
Inclusion
- Inclusion Criteria (Selected)
- Male and female healthy adult subjects
- Exclusion Criteria (Selected)
- Subject has protocol specified significant medical history.
- Subject is currently participating, or has participated within 30 days prior to study entry, in an investigational drug study.
- Subject has hypersensitivity or contraindications to naproxen, ibuprofen, or other NSAID.
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01139190
Start Date
July 1 2010
End Date
December 1 2010
Last Update
April 11 2016
Active Locations (2)
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1
Dallas VA Medical Center
Dallas, Texas, United States, 75216
2
Houston Center For Clinical Research
Houston, Texas, United States, 77074